Home NDC 15631-0228-2 HYOSCYAMUS NIGER
Product NDC 15631-0228
Requested package NDC 15631-0228-2
11-digit product format 156310228
Labeler code 15631
Product ID 15631-0228_ccd270d7-a945-4cf3-e053-2995a90a0f85
Type HUMAN OTC DRUG
Nonproprietary name HYOSCYAMUS NIGER
Dosage form PELLET
Route ORAL
Labeler Rxhomeo Private Limited d.b.a. Rxhomeo, Inc
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2015-10-02
Substance HYOSCYAMUS NIGER
Active strength 3 [hp_X]/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 15631-0228 15631-0228-2 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…
Additional Listing Data#
Finished product Yes
Brand name base HYOSCYAMUS NIGER
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYOSCYAMUS NIGER 3 [hp_X]/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4WRK2153H3 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 15631-0228-0 HYOSCYAMUS NIGER 100 in 1 PACKAGE PELLET 100 3 15631-0228-1 HYOSCYAMUS NIGER 200 in 1 PACKAGE PELLET 200 3 15631-0228-2 HYOSCYAMUS NIGER 400 in 1 PACKAGE PELLET 400 3 15631-0228-3 HYOSCYAMUS NIGER 750 in 1 PACKAGE PELLET 750 3 15631-0228-4 HYOSCYAMUS NIGER 2500 in 1 PACKAGE PELLET 2500 3 15631-0228-5 HYOSCYAMUS NIGER 12500 in 1 PACKAGE PELLET 12500 3 15631-0228-6 HYOSCYAMUS NIGER 500 in 1 PACKAGE PELLET 500 3 15631-0228-7 HYOSCYAMUS NIGER 1000 in 1 PACKAGE PELLET 1000 3
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 15631-0228 HYOSCYAMUS NIGER PELLET [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC] 3 Current NDC, Legacy NDC, 8 package rows 20210927_f7073b53-201d-4831-8784-00bdf95ce3ce.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 15631-0228-2 15631022802 400 PELLET in 1 PACKAGE (15631-0228-2) 400 pellet 2018-01-01 0000-00-00 No No Current